MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

Model Number 103695

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

The serial number of the device was requested but was not provided, therefore the expiration date, manufacture date, age of device and device identifier (udi) are unknown.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2019.It was reported that the patient underwent a pump exchange on (b)(6) 2019.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: it was reported that the patient underwent a pump exchange on (b)(6) 2019.Multiple requests for additional information, including patient identifying information and vad were sent to the customer; however, no response has been received at this time.The hmii lvas ifu lists all adverse events that may be associated with the use of heartmate ii left ventricular assist system and the proper actions associated with them.The current revision of the heartmate ii lvas ifu lists all adverse events that may be associated with the use of the heartmate ii left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8952099
• MDR Text Key: 160888412
• Report Number: 2916596-2019-04230
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010616
• UDI-Public: 00813024010616
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 103695
• Device Catalogue Number: 103695
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 101